All Medicus Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “All Medicus Co., Ltd.” (first 2005, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 171 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 125 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 260 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name All Medicus Co., Ltd. took a median 260 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 5 | 5 |
Review panels
Most recent All Medicus Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | NBW | 2017-10-13 | 260 |
| K130657 | LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE | NBW | 2013-07-15 | 125 |
| K083628 | GLUCODR AUTO SYSTEM | NBW | 2009-05-01 | 144 |
| K082328 | GLUCODR PLUS SYSTEM, MODEL AGM-3000 | NBW | 2009-02-27 | 197 |
| K050985 | GLUCODR SUPERSENSOR SYSTEM | NBW | 2005-10-07 | 171 |
Recalls
openFDA lists no recalls under a recalling firm named All Medicus Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under All Medicus Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “All Medicus Co., Ltd.” (first 2005, latest 2017), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by All Medicus Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name All Medicus Co., Ltd. is 171 days.
Which FDA product codes appear under All Medicus Co., Ltd.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 5).
Next steps
- See all 5 All Medicus Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NBW, All Medicus Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.